lal-ar-n-2005:study treatment for children high risk acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: the study objective is to improve the global results obtained with lal-ar-93 study, reaching an event free survival between 60-70%. identify patients with bad prognosis, with minimal residual disease,who can benefit of allogenic bone marrow transplantation

induction treatment systemic chemotherapy: prednisolone 60 mg/m2 /day, oral or i.v. x 21 days (1 to 22) 30 mg/m2 /day, oral or i.v. x 7 days (23 to 29) daunorubicin 30 mg/m2 , i.v. days 1,8,15 and 22 vincristine 1,5 mg/m2, i.v. days 1,8,15 and 22 l-asparaginase 10.000u/m2 i.m or i.v day 9,11,13,16,18,20,23,25 and 27 cyclophosphamide 500 mg/m2 i.v. days 1,2 and 29 intrathecal chemotherapy: days 1 and 22 according age: age \ 3 years methotrexate (mtx), mg 5 8 12 ara-c, mg 16 20 30 hydrocortisone,mg 10 10 20 patients with \<10% blasts in m.o (day 14), and in complete response on week 5 or 6, and without mdr, start consolidation-intensification phase. patients with \>10% blasts in mo day +14 or without cr after induction treatment, start consolidation-intensification phase and identifier a donor for a transplantation. consolidation/intensification (c.i.) two sequential cycles, alternating bloc i and bloc ii bloc i dexamethasone 10 mg/m2/d vo. days 1 to 5 and 5 mg/m2/d vo. days 6 and 7 vincristine 1.5 mg/m2/d, i.v. days 1 and 8 methotrexate 5 g/m2 24 hours infusion + af, day 1 ara-c 1 g/m2/12 h, i.v., days 5 and 6 mercaptopurine 100 mg/m2/d, oral, days 1 to 5 cyclophosphamide 500 mg/m2 i.v. el day +8 intrathecal chemotherapy day 1. bloc ii dexamethasone 10 mg/m2/d, v o. days 1-5 and 5 mg/m2/d, v o. days 6 and 7 vincristine 1.5 mg/m2/d, days 1 and 8 methotrexate 5 g/m2 24 h infusion + af, day 1 ara-c 1 g/m2 i.v/12 h, days 5 and 6 daunorubicine 30 mg/m2 i.v.day 1 l-asparaginase 20.000 u/m2/d, i.m. or i.v. day 7 intrathecal chemotherapy day 1 patients with cr and mrd negative, follow chemotherapy. patients with mdr \>0.01% after second cycle or considered previously mrd are candidates to allogenic transplantation after second cycle. reinduction/intensification treatment (r.i.) prednisolone 60 mg/m2/d, oral x 14 days (1-14) 30 mg/m2/d, oral x 7 days (15-22) vincristine 1.5 mg/m2, i.v. x 2 days 1 and 8 daunorubicine 30 mg/m2 i.v x 2 , days 1 and 8 cyclophosphamide 500 mg/m2 i.v. day 15 ----------------------------------------- methotrexate 3 g/m2 /24 h infusion + af day 29 mercaptopurine 50 mg/m2/d, oral, days 29-35 and 43-50 ara-c 1 g/m2/12 h., i.v., days 43 and 44 intrathecal chemotherapy , days 1, 15, 29 and 43 maintenanace treatment (m1) six cycles of: mercaptopurine 50 mg/m2/d, oral x 21 days (1-21) methotrexate 20 mg/m2/d, i.m. /week x 3 (1,7,14) prednisolone 60 mg/m2/d, oral x 7 days (22-28) vincristine 1.5 mg/m2 i.v.day 22 asparaginase 20.000 u/m2 i.m. day 22 intrathecal chemotherapy day 22 maintenance treatment (m2) diary mercaptopurine and weekly methotrexate at previous doses, until complete 24 months.

Eligibility criteria:
inclusion criteria: * high risk children with acute lymphoblastic leukemia exclusion criteria: * mature b-all (fabl3) * mixed forms of all * patients with coronary disorders, valvular or hypertensive cardiopathy * patients with chronic liver disorders * chronic pulmonary disorders * renal insufficiency * neurologic disfunctions * ecog 3 and 4

Keywords: acute lymphoblastic leukemia